A5073390275- Statistical Methods in Clinical Trials
- Optimal Experimental Design Methods
- Respiratory and Cough-Related Research
- Asthma and respiratory diseases
- Health and Medical Studies
- Atrial Fibrillation Management and Outcomes
- Clinical practice guidelines implementation
- Pediatric health and respiratory diseases
- Allergic Rhinitis and Sensitization
- Venous Thromboembolism Diagnosis and Management
- Renal cell carcinoma treatment
- Cardiovascular Function and Risk Factors
- Complementary and Alternative Medicine Studies
- Advanced Statistical Methods and Models
- Sports Science and Education
- Statistical Methods and Inference
- Herbal Medicine Research Studies
- Health Systems, Economic Evaluations, Quality of Life
- Cardiac Imaging and Diagnostics
- Hematopoietic Stem Cell Transplantation
- Cervical Cancer and HPV Research
- Cardiac Valve Diseases and Treatments
- Gastrointestinal motility and disorders
- Diabetes Treatment and Management
- Lipoproteins and Cardiovascular Health
University of Cologne
2014-2024
Institut für Medizinische Informatik, Biometrie und Epidemiologie
2002-2022
University of Insubria
2019-2022
University Hospital Cologne
2009-2019
German Sport University Cologne
2015
Kempten University of Applied Sciences
2013
PHV Dialysezentrum
2013
Max Planck Institute for Metabolism Research
2013
University Hospital Carl Gustav Carus
2013
Klinikum Passau
2013
Summary. A method for group sequential trials that is based on the inverse normal combining results of separate stages proposed. Without exaggerating Type I error rate, this enables data‐driven sample size reassessments during course study. It uses stopping boundaries classical tests. Furthermore, exact test procedures may be derived a wide range applications. The procedure compared with designs in terms power and expected size.
Lipoprotein(a) (Lp(a)) hyperlipoproteinemia is a major risk factor for cardiovascular disease, which not affected by treatment of other factors. This study sought to assess the effect chronic lipoprotein apheresis (LA) on incidence events in patients with progressive disease receiving maximally tolerated lipid-lowering treatment.In prospective observational multicenter study, 170 were investigated who commenced LA because Lp(a)-hyperlipoproteinemia and disease. Patients characterized...
Objective— Lipoprotein(a)-hyperlipoproteinemia (Lp(a)-HLP) along with progressive cardiovascular disease has been approved as indication for regular lipoprotein apheresis (LA) in Germany since 2008. We aimed to study the long-term preventive effect of LA and assess hypothetical clinical correlations apolipoprotein(a) (apo(a)) by analyzing genotypes phenotypes. Approach Results— This prospective observational multicenter included 170 patients Lp(a)-HLP (48.9 years median age at diagnosis)...
Sensitization rates to contact allergens vary between centers and are influenced by sex age. Eliminating the latter 2 factors standardization of data age sex, present analysis address possible differences remaining after elimination these confounders, analyzes other which might influence rates, e.g. MOAHL index. Overall standardized were well within range reported in previous studies may be regarded as representing “patch test population” Central Europe (e.g. nickel sulfate 12.9%, fragrance...
Objective. Systemic sclerosis (SSc) is a rare, heterogeneous disease, which affects different organs and therefore requires interdisciplinary diagnostic therapeutic management. To improve the detection follow-up of patients presenting with disease manifestations, an registry was founded contributions from subspecialties involved in care SSc.
Clinical trials are often concerned with the comparison of two treatment groups multiple endpoints. As alternatives to commonly used methods, T2 test and Bonferroni method, O'Brien (1984, Biometrics 40, 1079-1087) proposes tests based on statistics that simple or weighted sums single This approach turns out be powerful if all differences in same direction [compare Pocock, Geller, Tsiatis (1987, 43, 487-498)]. The disadvantage these multivariate methods is they suitable only for demonstrating...
Anticoagulation in cardioversion of atrial fibrillation is currently performed with unfractionated heparin (UFH) and oral anticoagulants, or without guidance by transesophageal echocardiography (TEE). Low-molecular-weight heparins may reduce the risk bleeding, obviate need for intravenous access, do not require frequent anticoagulation monitoring.In a randomized, prospective multicenter trial, we compared safety efficacy enoxaparin administered subcutaneously UFH followed anticoagulant...
Analysis of procedural effects in patients undergoing percutaneous mitral valve repair (PMVR) using the edge-to-edge technique is complex, and common methods to define regurgitation severity based on 2-dimensional (2D) echocardiography are not validated for postprocedural double-orifice valve. This study used 3D transesophageal (TEE) determine functional morphological PMVR.In 39 high-risk surgical with moderate severe regurgitation, TEE without color Doppler as well 2D transthoracic was...
Purpose This study aimed to evaluate a multicomponent, child-appropriate preschool intervention program led by teachers enhance physical activity (PA) and motor skill performance (MS) in 4- 5-yr-old children. Methods Evaluation involved 709 children (mean age, 4.7 ± 0.6 yr; 49.5% girls) from 41 preschools (intervention group, n = 21; control 20) the rural urban surroundings of two German cities. Children group received daily PA lasting 30 min homework over one academic year, which was...
Objectives To assess the efficacy and safety of trospium chloride (TCl, 20 mg twice daily) in treatment detrusor instability, compared with placebo. Patients methods In all, 208 patients were allocated at random to either TCl or placebo a double‐blind clinical study; treated for 3 weeks. Urodynamic values measured beginning end period. Adverse events recorded on patient diary cards. A confirmatory adaptive procedure one planned interim analysis was used evaluate efficacy. Results Trospium...
Planned interim analyses which permit early stopping or sample size adaption of a trial are desirable for ethical and scientific reasons. Multiple test procedures allow inference about several hypotheses within single clinical trial. In this paper, method combines multiple testing with adaptive whilst controlling the experimentwise error rate is proposed. The general closed principle, situation priori ordered hypotheses, application Bonferroni-Holm considered. practical demonstrated by an example.